Priming: Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.Ĭleaning: As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully. The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.Īdminister PROAIR HFA by oral inhalation only. In some patients, one inhalation every 4 hours may be sufficient. More frequent administration or a larger number of inhalations is not recommended. Sections or subsections omitted from the full prescribing information are not listed.įor treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours. ProAir® HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per Actuation, 200 Metered Inhalations Carton Text (ġ7 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.ħ.4 Monoamine Oxidase Inhibitors or Tricyclic Antidepressantsġ3.1 Carcinogenesis, Mutagenesis, Impairment of Fertilityġ3.2 Animal Toxicology and/or Pharmacology Consider alternative therapy in patients taking MAOs or tricyclic antidepressants. Monoamine oxidase (MAO) inhibitors and tricyclic antidepressants: May potentiate effect of albuterol on the cardiovascular system. (ĭigoxin: May decrease serum digoxin levels. (ĭiuretics, or non-potassium sparing diuretics: May potentiate hypokalemia or ECG changes. Patients with asthma should not normally be treated with beta-blockers. (īeta-blockers: May decrease effectiveness of PROAIR HFA and produce severe bronchospasm. Other short-acting sympathomimetic aerosol bronchodilators and adrenergic drugs: May potentiate effect. To report SUSPECTED ADVERSE REACTIONS, contact Teva Respiratory, LLC at 1-88 or FDA at 1-80 or DRUG INTERACTIONS Most common adverse reactions (≥3.0% and >placebo) are headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis. Hypokalemia and changes in blood glucose may occur. Immediate hypersensitivity reactions may occur. Use with caution in patients sensitive to sympathomimetic drugs and patients with cardiovascular or convulsive disorders. PROAIR HFA is not a substitute for corticosteroids. Need for more doses of PROAIR HFA than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. Discontinue PROAIR HFA immediately and treat with alternative therapy. Life-threatening paradoxical bronchospasm may occur. Hypersensitivity to albuterol and any other PROAIR HFA Inhalation Aerosol Components. Supplied in 8.5-g canister containing 200 actuations. Inhalation Aerosol: Each actuation delivers 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). PROAIR HFA inhaler should be discarded when the dose counter displays 0 or after the expiration date on the product, whichever comes first. (Ĭleaning information: At least once a week, wash the actuator with warm water, shake off excess, and air dry thoroughly. To prime PROAIR HFA, release 3 sprays into the air away from the face. Priming information: Prime PROAIR HFA before using for the first time, or when the inhaler has not been used for more than 2 weeks. Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise. Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours. Prevention of exercise-induced bronchospasm in patients 4 years of age and older. Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. PROAIR HFA Inhalation Aerosol is a beta2-adrenergic agonist indicated for: PROAIR HFA (albuterol sulfate) INHALATION AEROSOL See full prescribing information for PROAIR HFA Inhalation Aerosol These highlights do not include all the information needed to use PROAIR HFA safely and effectively.
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